Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement

• • Terminated Z-2447-2010 FDA Unclassified (pre-2012) ·initiated 30 Jun 2010

  Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compromise the sterility of the outside of t

510(k) Number

K040415 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Veritas Collagen Matrix

  Class II

  FDA 510(k) K030879 Active Cleared 24 Apr 2003

• Synovis Collagen Matrix (Tbd)

  Class II

  FDA 510(k) K122306 Active Cleared 8 Mar 2013

• Steerable Stylet

  Class II

  FDA 510(k) K040001 Active Cleared 9 Mar 2004

• Veritas Collagen Matrix (Dry)

  Class II

  FDA 510(k) K083039 Active Cleared 26 Nov 2008

• Veritas Dry Collagen Matrix, Veritas Dry or Veritas Psd

  Class II

  FDA 510(k) K041669 Active Cleared 27 Oct 2004

• Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration

  Class II

  FDA 510(k) K040119 Active Cleared 17 Mar 2004

See all devices from Synovis Surgical Innovations →